A. Field of Invention
The invention relates to the field of devices used for the collection and testing of a fluid specimen. The invention is particularly useful for collecting and testing biological fluid specimens, including human urine specimens. Other fluid specimens, such as biological fluid specimens in a veterinary setting or effluent samples in an industrial environment may also be collected and tested. The invention can be used to absorb a fluid specimen, seal it in a container or enclosure so that contact with persons transporting, handling or testing the specimen is prevented, subject the specimen to one or more tests which may include further transportation of the specimen, and disposal of the specimen sealed within the container or enclosure. The invention is highly resistent to tampering by the patient or during transport, and provides substantial advances in the safe handling of biological fluid specimens by medical personnel.
B. The Background Art
The typical biological fluid specimen collection and testing device used in the prior art consists of an open container, such as a cup, into which a patient places a biological fluid specimen, such as urine. The container may include a temperature indicator to aid in detection of a false specimen such as tap water, stored urine, or other fluids. If a fluid specimen with a temperature substantially greater than or less than normal body temperature, such as tap water, is placed into the container, then testing personnel could readily observe a suspicious temperature reading. After the patient has placed a specimen in the container, a cover is placed onto the container and the container is handed or transported to medical personnel, such as a nurse. The nurse then uncovers the container and dips various reagent strips into the specimen to test for the presence of controlled substances and to test for various medical conditions, such a diabetes. The specimen may be subjected to further testing procedure as needed. After testing of the specimen is complete, medical personnel typically pour the specimen down a drain and place the used container into a trash receptacle. In other industries, such as chemical manufacturing or environmental remediation, open containers are also used for collection of fluid specimens for testing.
A very important disadvantage of the prior art device is that it exposes the nurse and other persons to a high risk of contact with the specimen. In order to test the specimen, the nurse must remove the cover of the container. Uncovering the container sometimes results in spilling, splashing, dripping or leaking the specimen from the container, at times resulting in the nurse or other persons experiencing direct physical contact with the specimen. When the specimen is being tested, typically by dipping reagent strips into the specimen, the nurse is in very close physical proximity to the specimen, causing a substantial danger of spilling, splashing, dripping or leaking the specimen from the container, possibly resulting in direct physical contact between the nurse and the specimen. When testing of the specimen is complete and the nurse disposes of the specimen and container by pouring the specimen down a drain and placing the container into a trash receptacle, there is again the danger of spilling, splashing, dripping or leaking the specimen from the container and causing it to come into direct physical contact with the nurse or other persons.
Current awareness of and concern regarding communicable diseases such as hepatitis and the virus causing acquired immune deficiency syndrome (AIDS) makes the danger of contact between specimen and medical personnel very undesirable. The prior art fluid specimen collection container did little to mitigate this danger. The chance of contact between medical personnel and specimen is magnified for medical personnel who perform many specimen testing operations daily. Specimen testing is considered a hazardous and undesirable occupation due to the possibility of contracting a deadly disease. This can give rise to poor worker morale, the necessity of paying higher wages to specimen testing personnel, increased insurance costs, and the possibility of employer liability if specimen testing personnel are infected by contact with specimen.
Another important disadvantage of the prior art device is that keeping the specimen in an open container allows odors emitting from the specimen to escape into the ambient air. Although odor is not viewed as being as dangerous to medical personnel as direct physical contact with specimen, it is offensive to the senses and creates an unpleasant work environment.
Another disadvantage of the typical biological fluid collection and testing device used in the prior art is that it is subject to tampering such as specimen alteration or replacement, during transport from the specimen collection site to the specimen testing site. The cover of the typical prior art fluid collection device may easily be removed and the specimen altered or replaced. A disadvantage of the typical prior art fluid specimen collection device used in other industries, such as chemical manufacturing or environmental remediation, is that specimen collection and testing personnel are in danger of contact with specimen which may contain chemicals or other hazardous substances, and there is a danger of spilling some specimen and causing both health hazards and environmental contamination.
The medical industry has responded to some of the disadvantages of the prior art specimen collection and testing device by constructing tamper-proof containers from which a specimen cannot be removed or into which additional material may not be placed without visual evidence of tampering. An example of such a device is U.S. Pat. No. 5,133,470 issued to Abrams et al. Such tamper-proof containers, while partially effective in avoiding specimen tampering, offer no features to protect medical testing personnel from the possibility of direct physical contact with the specimen.
Another response by the medical industry to the disadvantages of the prior art specimen collection and testing device is U.S. Pat. No. 5,160,329 issued to Oxley. Oxley discloses a multi-compartment fluid specimen collection bag. Oxley's multi-compartment design is intended to capture multiple redundant specimen samples for various tests. The Oxley invention is unwieldy to use due to the necessity of providing a holder for the bag when the patient places a specimen into the bag. Oxley is also bulky and difficult to handle, both for the patient and for medical personnel. Oxley also requires a substantial volume of specimen in order to provide sufficient redundant specimen samples for multiple tests. Finally, due to the size and complexity of the Oxley invention, the cost of manufacture is too high to make it practical in high volume specimen testing settings.